FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
130129–130152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1989
DR. BOO LATEX EXAMINATION GLOVES
K893520 · LYY
Dynatech Medical Products
General Hospital · 105d
Cleared Aug 21, 1989
RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963
K893532 · CBN
Medipart Jerry Alexander
Anesthesiology · 105d
Cleared Aug 21, 1989
MECONIUM ASPIRATOR
K893649 · GCX
Gish Biomedical, Inc.
General Hospital · 98d
Cleared Aug 21, 1989
AEROSOL INHALATION MONITOR
K893665 · BWF
Vitalograph , Ltd.
Anesthesiology · 98d
Cleared Aug 21, 1989
SUCTION TIP
K893667 · JOL
Thomson & Shelton Instrumentation Co,...
General Hospital · 98d
Cleared Aug 21, 1989
EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405
K893692 · CIT
Diagnostic Systems
Chemistry · 97d
Cleared Aug 21, 1989
NOVA OXYGEN TENT
K893713 · BYL
Nova Health Systems, Inc.
Anesthesiology · 95d
Cleared Aug 21, 1989
KEYSTONE OXYGEN TENT
K893714 · BYL
Keystone Veterinary Supplies, Inc.
Anesthesiology · 95d
Cleared Aug 21, 1989
RUBAGEN
K893755 · LQN
Biokit USA, Inc.
Microbiology · 94d
Cleared Aug 21, 1989
ALBUMIN TEST (ALB) ITEM NUMBER: 65401
K893777 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 91d
Cleared Aug 21, 1989
FEVER LINE AND FEVER LINE PLUS
K893803 · KPD
Liquid Crystal Sciences, Inc.
General Hospital · 91d
Cleared Aug 21, 1989
SINGLE AND DUAL BAND DIPSTICK HCG TEST
K893873 · DHA
Ampcor, Inc.
Chemistry · 87d
Cleared Aug 21, 1989
MITEK STERILIZATION TRAY
K893886 · FLE
Mitek Surgical Products, Inc.
General Hospital · 83d
Cleared Aug 21, 1989
EMIT CONVENIENCE PACK: DIGOXIN ASSAY
K893910 · KXT
Syva Co.
Toxicology · 83d
Cleared Aug 21, 1989
TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD
K893912 · LCD
Technicon Instruments Corp.
Toxicology · 83d
Cleared Aug 21, 1989
TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD
K893913 · KLB
Technicon Instruments Corp.
Toxicology · 83d
Cleared Aug 21, 1989
NON-STERILE LATEX EXAMINATION GLOVES
K894013 · LYY
Nova Rubber Glove Industries Sdn. Bhd.
General Hospital · 76d
Cleared Aug 21, 1989
ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER
K894069 · JQW
Abbott Laboratories
Chemistry · 74d
Cleared Aug 21, 1989
MADEGOM LTDA. DENTAL DAM
K894120 · EIE
Madegom
Dental · 70d
Cleared Aug 21, 1989
LIQUID CHROMATOGRAPHY COLUMNS
K894141 · DPM
Supelco, Inc.
Toxicology · 69d
Cleared Aug 21, 1989
MARDX LYME DISEASE EIA (IGG) TEST SYSTEM
K894224 · LSR
Mardx Diagnostics, Inc.
Microbiology · 63d
Cleared Aug 21, 1989
DENLEY ANTHOS 2001 READER
K894270 · JJQ
Denley Instruments, Inc.
Chemistry · 60d
Cleared Aug 21, 1989
DENLEY WELLDILL 3
K894272 · JQW
Denley Instruments, Inc.
Chemistry · 60d
Cleared Aug 21, 1989
MARDX LYME DISEASE EIA (IGM) TEST SYSTEM
K894293 · LSR
Mardx Diagnostics, Inc.
Microbiology · 59d